Hiv
Conditions
Keywords
viral load suppression, surveillance, HIV treatment engagement, structural intervention
Brief summary
The Ryan White HIV/AIDS Program (RWHAP) for low-income people with HIV (PWH) is a key resource for reducing HIV health disparities and scaling up evidence-based interventions. As RWHAP serves \>50% of US PWH, RWHAP outcomes are vital to achieving "getting-to-zero"/ Ending the HIV Epidemic (EHE) Plan targets. As a grantee for RWHAP Part A (RWPA) funding distributed to the counties/cities severely affected by HIV, New York City (NYC) conducts regular HIV care continuum monitoring citywide and in its RWPA programs, which offer support services to reduce social and behavioral barriers to care/treatment. Local data consistently show lower viral suppression (VS) among RWPA clients in HIV care than among non-RWPA PWH in HIV care. Relative to NYC HIV cases overall, NYC RWPA clients (\ 14,000 per year) over-represent Black and Latinx PWH and high-poverty neighborhoods. To address local outcome disparities and to fill gaps left by data-to-care strategies and research focused on medical care (re-)linkage, the investigators propose to implement and rigorously evaluate the effectiveness of a novel 'data-to-suppression' (D2S) intervention among RWPA behavioral health and housing program clients who are in HIV care but unsuppressed. Surveillance-based reports on unsuppressed clients plus D2S capacity-building assistance will guide RWPA providers in targeting and delivering evidence-informed strategies to improve VS.
Detailed description
The investigators will implement and evaluate the Data-to-Suppression (D2S) intervention in Aim 1, which applies a cluster-randomized, stepped-wedge design. Agencies eligible for the trial will be matched in pairs and then randomized within pairs to the Early Implementation arm (receiving the D2S intervention in Periods 1 and 2, months 13-36) or the Delayed Implementation arm (receiving the D2S intervention in Period 2 only, months 25-36). Our design will also use baseline data from a 12-month pre-implementation period (Period 0, months 1-12), for which D2S reports will be retrospectively generated. Each period will include two rounds of report releases (six months apart), each with a 12-month look-back period. In both arms, clients without viral suppression (VS) will be followed forward for viral load (VL) outcomes after report issue date. Outcomes data will be derived from the NYC HIV Surveillance Registry, a population-based data source of longitudinal laboratory (VL, CD4) testing records on all diagnosed NYC PWH, regardless of medical provider within NYC, and for periods extending before and after RWPA program enrollment or discontinuation.
Interventions
OTHERData to Suppression (D2S)
Intervention components include (1) reporting and (2) capacity building to facilitate identification of and follow-up with PWH who are in care but virally unsuppressed. The NYC Health Department will send client-level, surveillance-based reports on individual clients' viral suppression status to the current Ryan White Part A behavioral health and housing service providers for those clients. The Health Department will also provide capacity building and technical assistance (TA) support to service providers on following up with clients flagged as unsuppressed, and on addressing barriers to viral suppression through root cause analyses and the development and implementation of D2S quality improvement projects. The intervention components are all delivered to Ryan White Part A providers by the Health Department, in order to enhance program resources to achieve and maintain viral suppression in the Ryan White Part A client population in NYC.
OTHERUsual practice
The NYC Health Department's usual practice with Ryan White Part A behavioral health and housing service providers includes sharing an annual aggregate surveillance-based report on viral suppression prevalence at each site and across all Part A sites (with trends for the past three years and breakdowns of viral suppression for specific populations in the latest year), a guidance document delivered with the aggregate viral suppression report, annual site visits to monitor program delivery, and on-demand quality improvement project guidance (for whatever Part A quality improvement project each site may identify and select).
Sponsors
City University of New York
New York City Department of Health and Mental Hygiene
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Stepped-wedge design: To isolate the effects of D2S on viral suppression, the investigators will randomize (within matched pairs and one trio) 27 RWPA-funded behavioral health and housing services provider agencies to early or delayed implementation, with delayed implementers receiving the usual NYC Health Department quality management supports (usual practice) until their assigned D2S implementation date, 12 months after the start of D2S at early implementing sites.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* For each stepped-wedge implementation period (Period 0, 1, or 2), clients eligible for trial inclusion must have: (1) ≥1 viral load (VL) test in the report year (evidence that they are in HIV care in NYC); (2) unsuppressed VL (≥200 copies/mL) at last reported VL test during that year; and (3) a reported service in one of the eligible programs/agencies during the report year. In addition, they must still have an open RWPA enrollment in one of the eligible programs and agencies and be presumed living at the time of report generation (two months following the end of the report year on which data are being shared with providers).
Exclusion criteria
* Agencies without current NYC RWPA funding for housing assistance or behavioral health (mental health, supportive counseling or harm reduction) services are excluded. Agencies with \<5 clients meeting the above inclusion criteria over three recent pre-implementation sample periods of data are also excluded (due to insufficient numbers of unsuppressed clients). Clients enrolled in NYC RWPA behavioral health or housing programs are excluded from the trial if they are virally suppressed, deceased, or lacking any evidence of NYC HIV care for a full year at the time a D2S report is issued. Given the potential lag in reporting to surveillance and the need to use the freshest available surveillance data for D2S reports, some clients may later be found to have died or to have a VL\<200 dated after their qualifying VL≥200 but prior to D2S report generation; such clients will be excluded post hoc from that round of follow-up due to VS at the time of intervention. Similarly, clients later reported (in programmatic data) to have been closed out of all eligible programs before the report issue date will be excluded post hoc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timely Viral Suppression | 6 months | Registry-reported VL \<200 copies/mL on any VL test dated in the six months after the client first appeared as unsuppressed on a D2S report for the period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Viral Suppression | 12 months | Time to first VL \<200 copies/mL after client's first appearance on a D2S report for the period |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDenis Nash, PhD
CUNY School of Public Health and Health Policy
PRINCIPAL_INVESTIGATORMary K Irvine, DrPH
New York City Department of Health and Mental Hygiene
Participant flow
Recruitment details
There is no client recruitment for this trial, which relies on data collected as part of surveillance and routine Ryan White HIV/AIDS Program (RWHAP) Part A reporting. The settings are 20 NYC community-based organizations and 7 hospitals funded through the RWHAP Part A grant to provide housing and behavioral health services. The 27 sites were matched in pairs (in one case, two smaller sites were matched to one larger one), and then randomized within pairs to early or delayed implementation.
Pre-assignment details
We excluded 6 RWHAP Part A sites with \<5 eligible individuals (clients in HIV care but virally unsuppressed) in any period, based on simulated D2S reports from 2018-2021. Those sites were not enrolled in the trial at all. The small numbers of potentially eligible individuals disqualified them. In addition, 386 clients from the 27 sites were excluded from the trial based on more mature surveillance data indicating they had not been eligible at the time that they were listed on a D2S report.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 53 Participants |
| Age, Categorical Between 18 and 65 years | 1371 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 200 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 556 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1099 Participants |
| Race (NIH/OMB) More than one race | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 64 Participants |
| Race (NIH/OMB) White | 248 Participants |
| Region of Enrollment United States | 698 Participants |
| Sex/Gender, Customized Cisgender man or boy | 960 Participants |
| Sex/Gender, Customized Cisgender woman or girl | 200 Participants |
| Sex/Gender, Customized TGNCNB* individual | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 119 / 601 | 121 / 893 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed